Www.monash.edu Research Ethics & Compliance Dr Simon Barrett Manager, Research Ethics & Compliance Monash Research Office.

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Research Ethics & Compliance

Dr Simon Barrett

Manager, Research Ethics & ComplianceMonash Research Office

www.monash.edu

Legislation:

• Prevention of Cruelty to Animals Act 1986• NHMRC Act 1992• ARC Act 2001• Prohibition of Human Cloning Act 2002• Research Involving Human Embryo Act 2002• Gene Technology Act 2000• Quarantine Act 1908• National Health Security Act 2007• Privacy Act 2000

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Codes of Practice

• NHMRC & ARC– Australian Code for the Responsible Conduct of

Research

– Australian Code of Practice for the Care and Use of Animals for Scientific Purpose

– The National Statement on Ethical Conduct in Human Research

– Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research

………………………………………….And many more

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Review Processes

• Monash University Human Research Ethics Committee

• Animal Ethics Committees (10 x local)

• Monash University Institutional Biosafety Committee

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What is Human Research?• Taking part in surveys, interviews or focus groups• Undergoing psychological, physiological or medical

testing or treatment• Being observed by researchers• Researchers having access to personal documents or

other materials• Collecting organs, tissues, fluids or exhaled breath• Access to information (individually identifiable, re-

identifiable or non-identifiable) as part of an existing published or unpublished source or database

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Risk and Benefit

• benefits justify the risks

• level of ethical review should reflect the level of risk

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Consent

• Participation is voluntary

• Consent must be informed– Sufficient information to understand the

purpose, demands, risks and potential benefits.

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Animal Ethics Review:

• All Monash scientific activities (teaching or research) using animals requires approval from a Monash AEC before work can commence.

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Animal Welfare General Principles:

• Justification• Responsibilities• Replacement• Reduction• Refinement

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Applications:

• Applications are made to local AEC• Must be reviewed by full committee in

“face to face” meeting.• Application usually require amendments• Often approved once amendments are

received by secretary and reviewed by chair.

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Gene Technology (GT) Act, 2000• Introduces a national scheme for the

regulation of GMOs in Australia

• Protect the health and safety of Australians and the environment

• Identify and manage the risks posed by or as a result of gene technology

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Requirements of the GT Act

• Organisations undertaking dealings are “Accredited”

• Dealings are classified based on their level of risk

– Exempt

– Notifiable Low Risk Dealings

– Licensed (non-intentional release & intentional release)

• Facilities for certain “Dealings” are “Certified”

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Funding Bodies

• Requirement of clearances– Funds aren’t released until clearance

approvals have been sited.

• Code for the Responsible Conduct of Research– “Compliance with the code is a prerequisite

for the receipt of NHMRC and ARC funding”

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What you need to know.That……

• Approvals for you work are in place• You names are added to any existing or

new approvals• Be familiar with the content of the

approved application• Be familiar with any conditions of

approval…..and comply with them